Arterial Line in Trauma Resuscitation
- Conditions
- Major Trauma
- Interventions
- Device: arterial line
- Registration Number
- NCT05996068
- Lead Sponsor
- National Taiwan University Hospital
- Brief Summary
Accident-related deaths is the 7th leading cause of death in Taiwan, and most of them is due to trauma from falls and traffic accident. Among trauma patients, the common cause of death is from hemorrhagic shock. Thus, real-time and accurate blood pressure monitoring is important for trauma patients. Incorrect blood pressure monitoring can lead to adverse events like traumatic cardiac arrest and shock and can also delay the time for intervention (fluid resuscitation, blood transfusion and operation). The current practice of blood pressure monitoring in trauma patient is by non-invasive blood pressure monitoring, which may be incorrect and not timely. Patient's body type and peripheral perfusion can both influence the result of non-invasive blood pressure monitoring.
With continuous and correct blood pressure monitoring, the resuscitation team can give adequate and timely treatment. In some trauma centers, arterial line insertion in trauma patients is a daily practice, while the evidence is inadequate and the potential benefit in unknown.
The main purpose of this study is to investigate the application of arterial line insertion in trauma patients. The study design is a prospective before-after study to exam whether arterial line insertion in trauma patients can reduce adverse event rate like hypovolemic shock and improve patient's outcomes.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 216
- Glasgow Coma Scale (GCS) 13 or less
- SBP < 90 mmHg
- Respiratory rate < 10 or > 29 breaths/min
- Fall from height > 6 meters
- High-Risk Auto Crash: Partial or complete ejection, intrusion > 30 cm any site, Need for extrication for entrapped patient, Death in passenger compartment
- Rider separated from transport vehicle with significant impact
- Penetrating injuries to head, neck, torso, and proximal extremities
- Skull deformity, suspected skull fracture
- Chest wall instability, deformity, or suspected flail chest
- Suspected pelvic fracture
- Suspected fracture of two or more proximal long bones
- Amputation proximal to wrist or ankle
- Active bleeding requiring a tourniquet or wound packing with continuous pressure
- Burns in conjunction with trauma
- Pregnancy
- Patient or family who are unable to obtain informed consent
- Known coagulopathy that is inappropriate for arterial line insertion
- Known peripheral arterial occlusion disease that is inappropriate for arterial line insertion
- traumatic cardiac arrest
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description trauma patients with arterial line insertion arterial line the after phase, actively recruited patients who are eligible for arterial line insertion
- Primary Outcome Measures
Name Time Method composite primary endpoint (including any hypotension, vasopressors usage, any cardiac arrest in ER, Shock index ) during ER stay, up to 6 hours including any hypotension, vasopressors usage, any cardiac arrest in ER, Shock index (HR/SBP)\>1
- Secondary Outcome Measures
Name Time Method arterial blood pressure trajectory during ER stay, up to 6 hours We will depict the arterial blood pressure trajectory for each patient.
prolong ICU admission up to 7 days define as \> 6 days of admission
30 days mortality rate mortality within 30 days of trauma event mortality within 30 days of trauma event
volume of fluid administration during ER stay, up to 6 hours any type of fluid administration
Area under curve (AUC) difference under different time measuring frequency 1/3/5/10 minutes We will use continuous blood pressure data and apply different intervals (1, 3, 5, and 10 minutes) to create a plot, then smooth it to calculate the area under the curve (AUC).
units of red blood cell transfusion during ER stay, up to 6 hours units of red blood cell transfusion
Trial Locations
- Locations (1)
National Taiwan University Hospital Yunlin Branch
🇨🇳Douliu, Taiwan